BioCentury
ARTICLE | Clinical News

Long Acting rFactor lX: Phase I/IIa data

July 26, 2010 7:00 AM UTC

In an open-label, dose-escalation Phase I/IIa trial (Study SYN-FIXFc-07-001) in 14 treatment-experienced patients with severe hemophilia B, single 1-100 IU/kg doses of IV rFIXFc were well tolerated and exhibited a 3-fold increased half-life compared to that of historical data for existing Factor IX therapies. There were no signs of injection site reactions or anti-rFIXFc antibodies, and no drug-related serious adverse events were reported. Data were presented at the World Federation of Hemophilia Congress in Buenos Aires. ...